Degenerative Disc DiseasePARTNERNCT04679896
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
A study testing MagnetOs Putty in people with Degenerative Disc Disease and Spine Fusion, run by Kuros Biosurgery AG at 1 site in United States.
Trial summary
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spine Fusion
- What is being tested?
- MagnetOs Putty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
- Male or female patient ≥ 18 years old.
- Patients with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion (L2 - S1).
- Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.
Who cannot join
- Requires > three-level fusion or expected to need secondary intervention within one year following surgery.
- To treat conditions in which general bone grafting is not advisable.
- In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g. defect site stabilization is not possible).
- In case of significant vascular impairment proximal to the graft site.
- In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
- In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
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- When intraoperative soft tissue coverage is not planned or possible.
- Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
- Receiving treatment with medication interfering with calcium metabolism.
- Women who are or intend to become pregnant within the next 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
About this study
Official title: A Prospective, Randomized, Single-center Study to Assess the Performance of MagnetOs Putty Compared to Local Autograft in Patients Undergoing up to Three-level Instrumented Posterolateral Lumbar Fusion (PLF).
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery.
In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Read the detailed description
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients with with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Day 0, Week 6, Month 3. CT scans will only be obtained at Month 6 and Month 12.
- Conditions
- Degenerative Disc Disease, Spine Fusion
- Being tested
- MagnetOs Putty
- Keywords
- Degenerative Disc Disease, Spine Fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetOs PuttyDevice
Procedure: Instrumented posterolateral spine fusion
| Study group | Role | What they receive |
|---|---|---|
| MagnetOs Putty | Experimental | MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side. Receives: Device: MagnetOs Putty |
| Local autograft | Other | Not described Receives: Device: MagnetOs Putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion by CT Scan
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Measured: Month 12
Secondary outcomes (7)
Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar fusion assessed by plain radiographs
Measured: Week 2, Week 6, Month 3
Posterolateral lumbar fusion assessed by CT-scan
The rate of posterolateral lumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes
Measured: Month 6
Interbody lumbar fusion assessed by plain radiographs
The rate of interbody lumbar fusion assessed by plain radiographs at Week 2, Week 6, Month 3, Month 6, and Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior vertebral bodies
Measured: Week 2, Week 6, Month 3, Month 6, Month 12
Functional Outcome by Oswestry Disability Index
Change in functional score using Oswestry Disability Index questionnaire. Patient-completed survey provides subjective percentage score for level of function (disability) in activities of daily living. Score rage 0-100 percent. The lower the percentages indicate higher functionality; 0-20% minimal disability, 80-100% significant disability.
Measured: Week 2, Week 6, Month 3, 6, and 12
General, back and Leg Pain by Visual Analog Pain Scale
Change in general, back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity.
Measured: Week 2, Week 6, Month 3, 6, and 12
Neurologic Status by Physical Exam
Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for the lower extremities, specifically in reflexes, muscle strength, sensory, and straight leg raise.
Measured: Week 2, Week 6, Month 3, 6, and 12
Success Rate
Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery
Measured: Week 2, Week 6, Month 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start13 Aug 2021
- Primary completion2 Aug 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Intra-patient control. Each patient serves as their own control.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthopaedic Institute of Western Kentucky, Simplified Clinical Data Systems, LLC
- Responsible party
- Sponsor
- Investigators
- Pascal Longlade, MD, Study director, Kuros BioSciences B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679896
- Sponsor's protocol ID
- MAG-920-059
- Acronym
- PARTNER
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-center Study to Assess the Performance of MagnetOs Putty Compared to Local Autograft in Patients Undergoing up to Three-level Instrumented Posterolateral Lumbar Fusion (PLF).
- ClinicalTrials.gov ID
- NCT04679896
- Acronym / sponsor ID
- PARTNER / MAG-920-059
- Conditions
- Degenerative Disc Disease, Spine Fusion
- Keywords
- Degenerative Disc Disease, Spine Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Orthopaedic Institute of Western Kentucky, Simplified Clinical Data Systems, LLC
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery.
In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Detailed description
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients with with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Day 0, Week 6, Month 3. CT scans will only be obtained at Month 6 and Month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment Intra-patient control. Each patient serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| MagnetOs Putty | Experimental | Device: MagnetOs PuttyMagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side. |
| Local autograft | Other | Device: MagnetOs Putty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
- Male or female patient ≥ 18 years old.
- Patients with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion (L2 - S1).
- Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.
Key exclusion criteria (10 listed)
- Requires > three-level fusion or expected to need secondary intervention within one year following surgery.
- To treat conditions in which general bone grafting is not advisable.
- In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g. defect site stabilization is not possible).
- In case of significant vascular impairment proximal to the graft site.
- In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnetOs PuttyProcedure: Instrumented posterolateral spine fusion | Device | Local autograft, MagnetOs Putty |
Primary outcome
Radiographic Fusion by CT Scan
Time frame: Month 12
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
7 secondary outcomes
Radiographic Fusion by Plain Radiographs
Time frame: Week 2, Week 6, Month 3
Posterolateral lumbar fusion assessed by CT-scan
Time frame: Month 6
Interbody lumbar fusion assessed by plain radiographs
Time frame: Week 2, Week 6, Month 3, Month 6, Month 12
Functional Outcome by Oswestry Disability Index
Time frame: Week 2, Week 6, Month 3, 6, and 12
General, back and Leg Pain by Visual Analog Pain Scale
Time frame: Week 2, Week 6, Month 3, 6, and 12
Neurologic Status by Physical Exam
Time frame: Week 2, Week 6, Month 3, 6, and 12
Success Rate
Time frame: Week 2, Week 6, Month 3, 6, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Longlade, MD study director
Kuros BioSciences B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagnetOs Putty in people with Degenerative Disc Disease and Spine Fusion, run by Kuros Biosurgery AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Fusion by CT Scan (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.